BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS

    K Number: K820995 · Decision May 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    1
    Review Days
    46

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
    K Number
    K820995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Ludek Optics, Inc.
    Date Received
    April 9, 1982
    Decision Date
    May 25, 1982
    Product Code
    KRO
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KRO), ordered by most recent decision date.

    Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stem Extension Line (USTAR II System)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Triathlon® Hinge Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTUNE™ Revision Hinge Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all